器官在芯片上的幻象:动物替代,塑料道和塑料要求:动物研究战争背后的虚假叙述
1Department of Biomedical Engineering, Rutgers University, Piscataway, NJ, USA, Center for Engineering in Medicine and Surgery, Massachusetts General Hospital, Boston, MA 02114, USA.
概括
器官芯片技术提供了补充数据,但由于预测范围有限,无法取代动物研究. 谨慎地将新方法方法 (NAM) 与动物研究相结合,对于患者安全至关重要.
科学领域:
- 生物医学工程 生物医学工程
- 毒理学 毒理学 毒理学
- 监管科学 监管科学
背景情况:
- 器官在芯片 (OOC) 平台被推广为动物试验的替代品.
- 本评论批判性地评估了支持OOC技术主张的证据.
研究的目的:
- 检查OOC平台取代动物研究的现有证据基础.
- 评估与OOC技术采用相关的限制和潜在风险.
主要方法:
- 对现有文献和证据进行批判性审查.
- 分析OOC平台的预测范围,验证和经济预测.
- 检查对患者安全的政策影响.
主要成果:
- 微生理系统提供辅助数据,但具有有限的预测范围.
- 限制包括选择性验证,材料吸收,非特定的终点和未经验证的代谢能力.
- 经济效益是基于乐观的建模,而不是经验数据.
结论:
- 动物研究的过早淘汰可能会危及患者的安全.
- 提倡谨慎地将新方法方法 (NAM) 与动物研究相结合.
- 强调需要独立验证和全球监管协调.
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